Hanoi workshop evaluates challenges in drug registration

At the workshop on Nov. 24 and 25, the speakers and participants discussed, analyzed, evaluated current challenges in practice while exchanging management experiences from other countries.

They reviewed the current status of the Vietnamese healthcare system and pharmaceutical legal framework to make recommendations and proposals on criteria and procedures to expedite the evaluation and approval process of drug dossiers.

According to Nguyen Thanh Lam, Vice Director of the Drug Administration of Vietnam, the unit has been increasingly accessing clinical records, bioequivalence dossiers, and biosimilar dossiers in recent times thanks to the development of science and technology. These are mandatory dossiers for NCEs and those with significant technological complexity.

Nguyen Thanh Lam, Vice Director of the Drug Administration of Vietnam, giving speech at the workshop. Photo courtesy of Drug Administration of Vietnam

Timely evaluation and approval of these products will ensure that Vietnamese people have early access to advanced new treatment therapies at reasonable prices.

Therefore, expediting the evaluation and issuance of drug circulation registration certificates is a key focus of the administration, and one solution is to enhance the quantity and quality of evaluation experts, Lam said.

The workshop serves as an opportunity for experts nationwide to update their knowledge, exchange ideas, and unify opinions, contributing to the direction of building pharmaceutical laws and related documents in the near future.

Magdalena Krakowiak, Vice-Chairman of IQMED-G&B, said that the removal of obstacles in drug registration as well as legislation in the pharmaceutical field helps Vietnamese patients have access to more high-quality products for better treatment.

She hopes that by collaborating on such workshops for open discussion and sharing experience, they will be able to find the best solutions for the challenges they are facing today and contribute to the improvement and advancement of the whole system.

“By learning from the experience of other countries, Vietnam is strongly going toward harmonization, thereby increasingly perfecting an effective and harmonious legal system. IQMED-G&B expects continuous collaboration with the Drug Administration and the Ministry of Health for the development of an advanced healthcare system in Vietnam,” she added.

Lam thanked all the speakers for their contributions.

He also highly appreciated the support and companionship of the International Quality Medicines, Generics, and Biosimilars (IQMED-G&B).

The workshop ended with a lot of positive outcomes, promising NCE, bioequivalent, and biosimilar drugs to be launched in Vietnam in the near future.